Software Validation Expert

9 hours ago


Palakkad, Kerala, India beBeeSystem Full time ₹ 18,00,000 - ₹ 24,00,000

As a computer system validation specialist, you will play a pivotal role in ensuring the quality and integrity of our products.

Key Responsibilities:
  • Develop and execute comprehensive test plans to ensure that computer systems meet regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to identify and mitigate risks associated with system validation.
  • Analyze and resolve complex technical issues related to system validation, utilizing your expertise in quality compliance and regulatory affairs.
  • Conduct regular audits and assessments to ensure compliance with FDA/EMA regulations, leveraging your knowledge of FDA regulated industries and quality management systems.

The ideal candidate will possess a strong background in computer system validation, quality compliance, and risk management. You will be responsible for developing clear and concise reports, working on complex projects, and meeting deadlines. If you are a detail-oriented professional with excellent communication skills and a passion for quality assurance, we encourage you to apply for this exciting opportunity.

Requirements:
  • Bachelor's degree in a related field or equivalent.
  • A minimum of 5-8 years of hands-on experience in computer system validation/quality compliance in a FDA regulated industry.
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, including QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Proven expertise in system validation, process validation, and GMPs.


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